Microsoft word - brainfunding_limoxifen en_jb _3_.docx

Limoxifen: Developing a new drug as a supplement for hormonal treatment of breast cancer Background According to the guidelines of treating hormone-sensitive breast cancer, hormonal therapy is prescribed for 5 years to women who have already received other treatments. This improves their prognosis. However, hormonal therapy can produce numerous side effects, such as reduced sexual desire, joint pain, and hot flushes. This is the case for medication such as tamoxifen, which reduce the effects of estrogens in the body. These drugs can also have a negative impact on cognitive functions such as verbal memory, verbal fluency and emotional functioning (manifested as lack of motivation and low mood). These and other side effects cause a substantial percentage of women to discontinue their hormonal therapy. A recent study has shown that around 1 in 6 women does not feel the therapy’s benefits outweigh the disadvantages. The reason that tamoxifen affects cognition and emotions is that the drug not only blocks the estrogen receptors in the mammary tissues, but also in the brain. Limbic Brain has developed a drug therapy that could prove effective against the aforementioned negative side effects of drugs such as tamoxifen, without compromising the beneficial effects. The research is still in its early stages, but with sufficient funding, further research into its efficacy can be started. Funding and research In order to realize our ambitious goals, we have opted for a crowdfunding project and have defined a ‘sub goal’ and a final goal. When the sub goal (€205,000) is reached, we will be able to study the effects of our medical treatments in 18 women who are experiencing cognitive and emotional problems as the result of anti-estrogen treatment. Reaching the final goal (€660,000) will enable us to also perform a more elaborate study on the efficacy of our new drugs in 60 women who are taking tamoxifen or similar drugs and are experiencing pychological problems. Depending on the amount of money gathered with this crowdfunding initiative, the studies will be set up as follows. Sub goal: €205,000. A pilot study on the efficacy of drug treatment in 18 women on tamoxifen or similar medication When the first goal – an amount of €205,000 – is reached, a double blind, placebo-controlled, randomized study will be conducted on the effects of this new drug treatment in 18 women who are taking tamoxifen or similar medication and are experiencing cognitive and emotional side effects. This pilot study will serve as the basis for further research in women on tamoxifen or similar medication. The purpose of this study will be to assess the assumed positive effects of our new drug treatment using questionnaires and neuropsychological tests. Study setup During a screening visit, it will be determined whether the participant is otherwise healthy. The study then consists of several visits to the research facility, during which neuropsychological tests will be conducted (e.g. to test memory and skills) and psychological questionnaires will be completed. Furthermore, the study consists of multiple periods of several weeks where the participant is given medication and will perform cognitive tasks in the laboratory. After each period there will be extensive safety assessments. Final goal: €660,000. A study on the efficacy of drug treatment in 76 women on tamoxifen or similar medication When the second goal – a total amount of €660,000 – is reached, the aforementioned study will be conducted as well as a double blind, placebo-controlled, randomized study on effects the of this new drug treatment in another 60 women who are taking tamoxifen or similar medication and are experiencing cognitive and emotional side effects. This study will be longer and more extensive than the pilot study, in order to investigate longer term safety and efficacy. It will also include the assessment of multiple biological (including genetic) and psychological variables in order to develop a tool that can predict the efficacy of the new medication for each individual. Study setup During an extensive screening visit, the problems experienced by the patient will be mapped using questionnaires, an interview by a psychologist and neuropsychological tests. A medical intake will be performed to determine whether the patient is physically healthy. Moreover, blood will be drawn for the different biological and genetic assessments. These will be used for the development of a tool aimed at a personalized drug treatment for these women. During this study subjects will be provided with medication for a longer period of time and will be completing questionnaires on a weekly basis and performing neuropsychological tests. After each medication period there will be a follow up visit. Both studies will start only after we have approval of a medical ethics committee / institutional review board. Costs A total of 78 women will participate in both studies, for which €660,000 is budgeted. Apart from the costs for the study activities and assessments described above, these costs include: - Study medication - Personnel costs - Submission to the ethics committee - Recruitment and reimbursement of participants - Managing and monitoring the clinical database - Analyzing the results and writing a scientific paper Benefits and risks Investing in this project is possible starting from €50. You will get a bond with a term of two years and a return of 20% over two years. This corresponds to an effective yield of 9.5% per year. After the two years the bond, including the interest will be paid back to you. In addition, there are attractive extras for higher investments: €500 or higher: you are eligible to attend a lecture on the interaction between brain and body. €2,500 or higher: you are eligible to attend a diner pensant and a lecture. If you wish to invest more than €20,000, please contact us directly at info@brainfunding.nl Lecture Medical treatments based on a personalized approach have been attracting a lot of attention. A medical problem can manifest itself in a similar way in different people, but can have very different psychological or genetic causes. There are processes going on in your body that control your behavior, your mood and actions without you being aware of it. How does this work, and how does science use the knowledge of these processes for developing personalized methods that can influence abnormal processes in a positive way? During the lecture, you will be introduced into the interesting interaction between body and mind and the way research is being done into treatments based on a personalized approach. ‘Diner pensant’ You will be invited for a diner pensant. Prior to every course of the dinner, a short introduction will be given into an interesting subject with a medical, societal or scientific touch. During the dinner, you will have the opportunity to discuss this with the others at the table. Risks Medical research is a necessity, but financially speaking it is risky investment. In order to protect you as an investor, we have built a construction in which the risk involved in the research is significantly reduced. Your loan is provided to Limbic Brain Company BV. Limbic Brain Company will finance the research project of Limoxifen BV. Limbic Brain Company has a significant equity interest in Emotional Brain, which has the promising products Lybrido and Lybridos (medication for women with reduced sexual desire) in an advanced stage of research. Revenues, which are derived therefrom are used to pay back your investment. The benefit of the development which Lybrido and Lybridos has already gone through reduces your risk is significantly.

Source: http://brainfunding.nl/en/wp-content/uploads/sites/2/2013/11/breast-cancer.pdf